Ablation of Subcutaneous Contraceptive Implants in the Op... | NCT05932537

Studies
Ablation of Subcutaneous Contraceptive Implants in the Operating Room

NCT05932537

Sponsor

Hospices Civils de Lyon

Status

Unknown status

Last Update Posted

Nov 13, 2023Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Contraceptive Usage

Interventions

Preoperative visualization techniques

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2022Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Dec 14, 2022

First Submission Date that Met QC Criteria

Jun 27, 2023

First Posted Date

Jul 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2023

Last Update Posted Date

Nov 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The ablation of subcutaneous contraceptive implants is usually performed in consultation under local anesthesia. However, it happens that the implant was placed too deeply or that it migrated too deeply making it impossible to remove it in consultation. These patients should then be referred to reference centers so that the explantation takes place in the operating room. The investigators propose to describe their techniques for preoperative visualization of the implant and their techniques for surgical explantation for educational purposes.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
subcutaneous contraceptive implants		patients who have benefited from explantation of a subcutaneous contraceptive implant in the gynecology operating room	Procedure: Preoperative visualization techniques

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Preoperative visualization techniques	Procedure	describe techniques for pre-operative visualization of subcutaneous contraceptive implants	subcutaneous contraceptive implants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ultrasound for visualization of implants	Percentage of patients with an ultrasound to visualize the implants	preoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women over 18
patient who underwent explantation of a subcutaneous contraceptive implant in the gynecology operating room
intervention between 2018 and 2022
person having expressed his non-opposition

Exclusion Criteria:

explantation outside the operating room
inability to understand the information given
person deprived of liberty
person under guardianship

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

This study covers all patients who underwent explantation of a subcutaneous contraceptive implant in the gynecology operating room of the Hôpital Femme Mère Enfant, between 2018 and 2022.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gynaecology Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon	Recruiting	Bron		69677	France

Condition Browse Module

MeSH Terms

ID	Term
D003268	Contraception Behavior

Ancestor Terms

ID	Term
D043762	Reproductive Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided